HIV/AIDS
Conditions
Interventions
Enhanced Standard of Care
Sponsors
US National institute of Mental Health
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Enrollment criteria for the intervention augmentation (Aim 1) participants will be as follows: 1. Young women Inclusion criteria - Young woman (age 16-24 years; see emancipated minors description below) - Interest in PrEP - Sexually active within 3 months - Residence in the Kisumu County - Phone ownership - Ability to understand KiSwahili, DhoLuo, and/or English Enrollment criteria for the type 1 effectiveness-implementation trial participants (Aim 2) will be as follows: Inclusion criteria - Young woman (age 16-24 years; see emancipated minors description below) - Initiating PrEP at the recruitment site (this criterion subsumes all necessary safety assessments for starting PrEP, including HIV-negative status and for those taking FTC/TDF normal renal function and lack of Hepatitis B infection) - Residence in the Kisumu County - Phone ownership - Ability to understand KiSwahili, DhoLuo, and/or English Inclusion of emancipated minors Per Kenyan national guidelines, 16- and 17-year-old girls are considered to have reached the age of majority if they have been pregnant or diagnosed with an STI. Such individuals will therefore not require parental consent to participate in this study. However, parental consent will be obtained for other 16- and 17-year-olds who wish to participate in the study, in addition to informed consent for the minor. As described below, study staff will host community events and meet with a community advisory board to allay potential concerns about studying sexual health in a young population.
Exclusion criteria
Exclusion criteria: Exclusion criteria- inability to provide informed consent (e.g., intoxication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be prevention-effective PrEP persistence at Month 9 (a follow-up time point common to all PrEP formulations). | — |
Secondary
| Measure | Time frame |
|---|---|
| Prevention-effective PrEP persistence at other time points.;Prevention-effective persistence with alternative definitions of HIV prevention need: Given current uncertainty in accurately assessing HIV risk, we will explore other definitions, based on behaviors (e.g., alcohol use, partner’s risks) and clinical data (e.g., STIs).;Additional effectiveness outcomes. - Prevention-effective adherence (i.e., executed use during a given time period) using CAB-LA injections (yes/no) plus dapivirine release level, and DBS TFV-DP concentration, in the setting of ongoing HIV prevention need. Self-reported adherence measures will also be explored (days with ring inserted, number of oral doses taken, ability to adhere as directed to ring use or oral doses) - Use of family planning based on kit use (intervention arm) or clinic pick-up (enhanced SoC arm). - STI testing per self-swabs (intervention) or clinic-based tests (enhanced SoC). | — |
Countries
Kenya
Contacts
Public ContactKevin Kamolloh
Study Coordinator
Outcome results
None listed